Treats infection caused by various strains of influenza A virus. ANDA 218598, held by Zhejiang Jutai Pharm. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 218598 (Amantadine Hydrochloride), held by Zhejiang Jutai Pharm, was first approved by FDA on Sep 26, 2024, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride100MG · tablet;oral | Amantadine Hydrochloride | Rx |
| Jul 10, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 26, 2024 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
